Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2006 by Odense University Hospital. Recruitment status was Active, not recruiting

First Received on September 2, 2005. Last Updated on October 10, 2006 History of Changes

Sponsor:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00145353

Purpose

The main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin Aspart at meals together with NPH insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and when the patients in both periods simultaneously take extra insulin at meals if high blood glucose values are found before meals.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus	Drug: Insulin NovoRapid versus Actrapid	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin Insulin beef Insulin aspart

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

Meal-regulated insulin time two peaks after the two intervention periods

Estimated Enrollment:	16
Study Start Date:	November 2004
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening.
AGe: 18-60 years
BMI: 18-27.5
No nefro- or neuropathy; i.e. S-creatinin below 120 μmol/l and normal monofilament examination
Written informed consent

Exclusion Criteria:

Pregnant women or patients planning to become pregnant during the investigation period
Reduced eyesight; i.e. visus > 0.3 evaluated at the latest eye exam.
Patient lacking the ability to sens insulin sensitivity
Serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.
Suspicion of abuse or non-compliance
Participation in another clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145353

Locations

Denmark
Diabetes Research Center
Odense, Funen, Denmark, 5000

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator:

Iben B. Jacobsen, MD

Odense University Hospital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00145353 History of Changes
Other Study ID Numbers:	007
Study First Received:	September 2, 2005
Last Updated:	October 10, 2006
Health Authority:	Denmark: National Board of Health

Keywords provided by Odense University Hospital:

type 1 diabetes mellitus
hypoglycaemia
insulin profiles

growth hormone
cortisol
glucagon

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases

Immune System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012